Fibromyalgia Pipeline

The word fibromyalgia (FM) comes from the Latin fibra, which stands for fibrous tissues (such as tendons and ligaments), and from the Greek myo (muscle) combined with algos meaning “pain.”

In the past, that is, since the early 1800s, fibromyalgia was already known but under other names. In 1904, for example, it was called fibrositis by Gowers, thus emphasizing its aspect related to supposed inflammatory-type phenomena. William Richard Gowers, describing a bizarre form of low back pain in young adults attributed to inflammation of the fibrous tissue of muscle masses, coined the term “fibrositis,” hypothesizing the inflammatory (inflammatory)origin of the disease. In the postwar period it was realized that the term “fibrositis,” by which the disease was still defined, was not appropriate because there was no particular evidence of its inflammatory nature. This is why in 1981 Muhammad B. Yunus and Alphonse T. Masi proposed the term fibromyalgia, which had already been anticipated by Philip Kahler Hench in 1976 and is now universally accepted.

The disease

Fibromyalgia is also called fibromyalgia syndrome and, in general, is a condition characterized by chronic muscle pain that is accompanied by stiffness.
Thus, it is a rheumatic disease that affects the muscles causing increased muscle tension, that is, all the muscles from the scalp to the soles of the feet are in constant tension.
The resulting disorders are many:
– Localized pain usually in the neck, shoulders, back, and legs;
– stiffness and thus limited mobility and swelling sensation at the joints;
– Chronic fatigue due to constant muscle tension;
– Light, disturbed and unrestorative sleep;
– Tendon pain.

The causes of fibromyalgia
The origin of fibromyalgia lies in a combination of factors.
The many studies done on the condition have reported numerous neurotransmitter alterations in the central nervous system. In this sense, fibromyalgia can essentially be considered a disease of intercellular communication.
The two main features of fibromyalgia are hyperalgia and allodynia.
Hyperalgia means a very intense perception of pain in response to mild painful stimuli; whereas allodynia means the perception of pain in response to non-painful stimuli.
In patients with fibromyalgia, both hyperalgesia and allodynia are two clinical conditions that are persistent and widespread.
In fibromyalgia syndrome, the onset of pain is due to a deficit of blood supply to the muscles. This deficit results, in turn, from dysfunction of neurotransmitters and, in particular, serotonin and norepinephrine.
Characteristic of fibromyalgia, as well as other neurodegenerative disorders, is that the course of symptoms varies according to external factors that can cause worsening: hormonal factors (during the menstrual period there is worsening and also in case of thyroid dysfunction), climatic factors (pains become more acute in the intermediate seasons) and stress (tensions at work, quarrels, arguments).

Fibromyalgia symptomatology
Fibromyalgia is a disease that, in addition to the already mentioned pain and fatigue, causes a set of symptoms that go on to involve various parts of the body: from theosteoarticular apparatus and muscle tohearing (tinnitus, whistling or vibration within the ear), to gastrointestinal disorders (digestive problems, abdominal pain, acidity, irritable bowel syndrome) and to theurinary tract (increased urgency at urination, pain in the bladder) and genital (dysmenorrhea and vaginismus).
In addition, changes inbalance (unsteadiness, lurching, dizziness), cognitive disturbances (concentration difficulties and short-term memory loss), tachycardia, changes in body temperature (cold or heat spread throughout the body), cramps, and uncontrolled limb movements in sleep may also occur.
In the latter case, it should be pointed out that night rest in fibromyalgics is definitely impaired: frequent awakenings and unrestorative sleep. This is due to the so-called alpha-delta anomaly, which is a condition whereby, once deep sleep is achieved, there is an abrupt return to surface sleep.
Further penalizing fibromyalgia sufferers are headaches that are characterized as migraines or as nuchal, temporal, or supraorbital headaches; jaw or jaw pain ; and sensory disturbances (tingling and numbness).
A large proportion of fibromyalgia patients report hypersensitivity to numerous medications, seasonal allergies, and food allergies.

Treatments: what approaches

Until a decade ago, fibromyalgia was rarely diagnosed, mainly because it was considered a disease of a psychogenic nature and, therefore, difficult to treat.
Today, however, it can be said with certainty that the condition can be effectively treated by relying on drug therapy to correct the serotonin deficits that cause it.
In addition, there are also nonpharmacological approaches that can modify theneurovegetative hyperactivity characteristic of the disease.

Drug therapy and related efficacy studies
Tricyclic drugs (amitriptyline and trazodone) and selective serotonin reuptake inhibitors (fluoxetine, paroxetine, sertraline, citalopram) can be used to relieve pain, improve sleep quality and overall well-being in patients with fibromyalgia.

By analyzing the scientific literature regarding the treatment of fibromyalgia with antidepressants, and in particular 18 randomized trials with a total of about 1,427 subjects involved, it was possible to calculate that in North America and Europe about 6 percent of the population suffers from this condition, or 5 million Americans and 10 million Europeans.
Antidepressants considered in the 18 studies included tricyclics and tetracyclics (TCAs), serotonin reuptake inhibitor antidepressants, serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors (MAOIs).
Overall, the results indicate that TCAs are effective in reducing pain, while selective serotonin reuptake inhibitors do not give good outcomes.
It should also be pointed out that all these drugs act as antidepressants in patients who, due to the disease, suffer from various forms of depression.
At present, however, there are still no long-term studies to provide firm recommendations in the use of antidepressants.

Before any type of therapy is started, it is essential to very carefully analyze the patient’s medical conditions, if any, for possible side effects.
In fact, there are no firm data on long-term treatment of fibromyalgia with antidepressants, which means that regular follow-ups are needed to understand the extent to which the effects are worthwhile and whether the benefits are not undermined by side effects.

Nonpharmacological approach
All kinds of nonpharmacological approaches have been performed experimentally to treat fibromyalgia patients. This means that it is difficult to make an objective assessment of what is effective or what is merely the result of suggestion.
This is why it is necessary to rely solely and exclusively on scientific studies and to clarify about physical therapies, such as TENS, iontophoresis and thermotherapy, what kind of effectiveness they have. To date, TENS demonstrates therapeutic success in about 70 percent of patients treated in comparison with all other therapies that prove no better than a placebo.

There are at least two studies that testify to the effectiveness of electromyographic biofeedback (measures the activity of various muscle groups to provide the subject with continuous, real-time information about his or her own state of muscle tension).
Undoubtedly the nonpharmacological therapy that has radically changed the treatment approach and also the prognosis of fibromyalgia in recent years is muscle relaxation therapy based on Schultz autogenic training, cognitive-behavioral therapy, and relaxation based on Ericksonian techniques (brief therapy).
Ericksonian hypnotherapy does not consider the individual’s unconscious like psychoanalytic therapies. Instead, it views the human unconscious as a great resource that, just as it guides the autonomic nervous system to ensure survival, can be guided to make the organism function better.
Ericksonian therapy, considers that the unconscious tries to act for good, as if to defend what it believes is at risk. This approach proves to be more effective than the other two because the positive therapeutic effect usually occurs as early as after the fifth session, valid parameters for testing effectiveness are obtained (number of tender points, i.e., points of soreness, asthenia, widespread pain, sleep problems), and a beneficial effect is guaranteed at least until the sixth month after the treatment is discontinued.

Physical activity
While there is specialist literature that points to physical activity as fundamental to the treatment of fibromyalgia, many sufferers report that it leads to marked worsening of symptoms (fatigue and pain). This happens because fibromyalgia patients typically have increased muscle tension, which, in turn, causes decreased blood flow that causes lack of oxygen and lower exercise tolerance. It is recommended, therefore, to practice some light movement to make sure that the muscles do not lock up but always in the order of not over-fatiguing the muscles.

As with all diseases, the type of diet plays a key role in fibromyalgia.
The most credited advice is that of physician Thomas Weiss (, who for fibromyalgia sufferers indicates to:
● Reduce white and refined sugars as much as possible, preferring brown sugar;
● Little red meat and predominantly vegetarian diet. Prefer white meat, eggs, and dairy products if you do not have high cholesterol or dairy intolerance;
● lots of fruits and vegetables for the antioxidant effect and the necessary supply of minerals;
● Well-cooked whole grains, seasoned with olive oil and herbs;
● limit consumption of tomatoes, potatoes, eggplant and peppers, which easily trigger food intolerance phenomena with manifestations at the muscle level;
● Limit salt to ward off stagnation and edema. For the same reason, it is essential to ingest plenty of water, infusions and herbal teas.

The development of a new drug for fibromyalgia

Recently, Nevia Biotech’s research team has identified the possible use of a molecule endogenous to the human body capable of developing therapeutic actions that lead to the near disappearance of symptoms within an acceptable time frame, and without evidence of the severe side effects inherent in antidepressant drugs currently in use.

Currently, ongoing studies are focused on the preclinical phase of drug development.

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